How do I Start My Own Clinical Diagnostics Laboratory?

How do I go about starting my own Clinical Laboratory in which private Doctors, Clinics and even some private hospitals use to send their patient's specimen for a variety of health care management. Currently I have a degree in Microbiology, but I want to go back to school for a Clinical Lab certificate, and then on to a Master's degree in Public Health. What are some of the key steps, besides my education, do I need to take? I know I have to get licensure for my lab. How do laboratories establish cliental with insurance companies, doctors, hospitals, and clinics. Im sure there is marketing involved.

I'm sure the startup costs would be quite high as the lab would need to be licensed, and meet all safety and biohazard rules. All equipment would have to be calibrated. New equipment can be astronomical in cost, although if you could get away with 10 year old equipment, it might be available for pennies on the dollar.

I would look at trying to fill a niche that currently isn't filled. Talk to some local physicians and clinics to find out where they currently have their lab work done. Find out what labs are now being sent out of town.

If you could competitively do labs that normally are sent out of town, then you might be able to compete.

In addition to buying older equipment suggested by CliffordK, you might also lease the more expensive instruments, especially from the smaller makers who, like you, are willing to be more flexible in order to compete.

One way for small startups to compete is to give the healthcare providers what they want instead of the "cookie cutter" approach that the big labs typically provide. It's the customization from small businesses that often distinguishes them from the big corporate businesses, in this case the big ones being Quest, LabOne, etc. I suggest reading "The Customer-Oriented Laboratory" by William Umiker.

Talk to potential customers (the actual doctors, nurses, PAs, etc) and see how they are disappointed with the service they receive from the big labs. It could be the inability to order a customized panel — or partial panels — of tests, or wanting quantitative results instead of qualitative results, or the turn-around time, or the form of the results (online, faxed, and/or hardcopy, etc). Or simply the ability to find a lab that will test a particular substance. You might end up testing something like fecal samples.

One way to compete is to become knowledgeable about the tests and the substances being tested. The big labs will just provide results without any human willing to say much to customers about what the results mean. This is mostly true because big businesses segregate the work into narrowly-defined positions. The technicians that run the tests are a bunch of pipetters and button pushers. The managers who might know a little more are too busy to talk with customers. The attitude is also that the doctor ordered the test, so they should know what the results mean, but in reality, doctors sometimes don't know, especially when there are various ways in which to test for a substance (HPLC, GC/MS, etc). How do the tests and their results differ from one another? A lab might typically interface with a nurse or PA instead of a doctor, and these employees would appreciate detailed info that they can then pass along to the doctors, making them more valuable to their bosses.

Another consideration is that you will compete with the increasingly common small POC (Point-Of-Care) instruments. Their advantage allows doctors to bill for the tests run in their offices, instead of allowing an outside lab to take the profit. The little I have seen of these POC instruments is that some nurses and other doctor's office employees aren't so technically-minded as to operate them properly, making the results dubious. I have seen containers of test strips left open 24/7, and I have seen samples left on the counter over the weekend to be tested on Monday. No one seems to know that these bad habits invalidate test results. The makers of these devices are trying more and more for them to be foolproof, but that's not to say that the people using them won't make these types of procedural mistakes.

You will most likely require a Lab Director, who could be part-time, depending on your state's requirements.

You might want to consider areas other than healthcare. There are other reasons for microbiology testing than medicine. You could look into microbiology testing for environmental purposes, for example lakes and streams, agriculture, food safety, and quality control in other types of manufacturing.

Thinking about what Lmnre said.Obviously there are both good and bad things about tests like a rapid strep test. Some tests you might be able to run just using standard sample tools.

You might also consider employing your own courier service. Perhaps hitting the local hospitals 3 times a day (or whatever seems appropriate), as well as "on-call" for certain pickups.

One of the things you will also have to consider is whether you wish to have patients. I.E. do you want to do phlebotomy? Urine samples, & etc in your office?

One other HUGE market is drug testing for both athletics & businesses. Often sending someone onsite for sample collection.

I have no doubt that over the next decade genetic testing & DNA sequencing will be growing very quickly. The biggest issue with that is that the technology will also be changing quickly. It is a field that you could easily get into the ground floor on which is very good for start-up businesses, but it is possible that you could be buying very expensive equipment that would have a very short lifespan.

One other HUGE market is drug testing for both athletics & businesses.

Yes, and the last I knew, very few labs test hair for drugs, a rather long and intensive process.

Don't forget toenails and fingernails.

I'm surprised that professional sports don't require hair, toenails, and fingernail tests. For example, it seems like some people believe it is ok to take all the steroids one wants, as long as one stops a few weeks before a competition.

Personally, I would think employer random hair/toenail/fingernail testing is a bit excessive, but I could imagine a business doing it for new hires.

If you do patient interactions, you may need gender appropriate employees, although when collecting at an office, sometimes one can enlist the aid of a manager.

If you do patient interactions, you may need gender appropriate employees, although when collecting at an office, sometimes one can enlist the aid of a manager.

I've collected hair from women, but I suspect you're talking about urine. Enlisting help probably nullifies the chain of custody, even if the manager is a DATIA certified collector. And it would make for an awkward employment relationship after the collection.

As for starting a lab in general, I seriously recommend getting a few years in clinical labs just to see how they function (and how they don't) ... and talk a lot with employees in those labs, which is where online forums come in handy. Then you'll know how to compete or find a niche. ... unless you have enough money to do it right the second time.

How do I go about starting my own Clinical Laboratory in which private Doctors, Clinics and even some private hospitals use to send their patient's specimen for a variety of health care management. Currently I have a degree in Microbiology, but I want to go back to school for a Clinical Lab certificate, and then on to a Master's degree in Public Health. What are some of the key steps, besides my education, do I need to take? I know I have to get licensure for my lab. How do laboratories establish cliental with insurance companies, doctors, hospitals, and clinics. Im sure there is marketing involved.

Hoping everything is going well so far in your laboratory endeavor!

As someone who started a lab a couple years back, I was hoping I could give you a few ideas. 1: Getting your clientele is just like anything else. Contact your potential clients and let them know what services you are going to offer and the price. Once you get a few on board, word of mouth will be huge.

2. Like CliffordK said. Check out some used laboratory equipment. They usually come with a warranty and work great. Check out newbielink:http://zamscientific.com [nonactive], I bought a few items from them and had a great experience.

Hope this all helps. And let me know if you come across any other questions.

I want to open a new clinical diagnostic laboratory (chemistry, hematology and toxicology) at bay area. It will be mid-size lab. But I don't know anything about process? where should I start from. I need your advices. Does anyone help me regarding this issue. Thanks